Radiopaque And Septum-Based Indicators For A Multi-Lumen Implantable Port

ABSTRACT

An implantable multi-lumen access port including indicators for ascertaining characteristics of the port is disclosed. In one embodiment, the access port comprises a housing that defines a first reservoir and a second reservoir. A first septum and second septum are respectively coupled with the housing to provide selective access to the first and second reservoirs. Each septum includes a plurality of protrusions defined about a periphery thereof that are palpable after implantation of the port in a patient to determine a relative position of the first septum with respect to the second septum. A radiographically observable indicator is also included on a base of the housing, so as to provide information relating to a characteristic of the dual-lumen port, such as suitability for power injection of fluids. The indicator in one embodiment includes a substantially rigid radiopaque component.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.12/267,160, filed Nov. 7, 2008, now U.S. Pat. No. 9,579,496, whichclaims the benefit of U.S. Provisional Patent Application Nos.60/986,246, filed Nov. 7, 2007, and entitled “Septum IdentifyingOrientation in a Multi-Lumen Port,” 60/986,247, filed Nov. 7, 2007, andentitled “Radiopaque Indicators for Implantable Ports,” and 61/110,507,filed Oct. 31, 2008, and entitled “Radiopaque and RadiographicallyDiscernible Indicators for an Implantable Port,” all of which areincorporated herein by reference in their entireties.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toan implantable multi-lumen access port including indicators forascertaining characteristics of the port. In one example embodiment, theaccess port comprises a housing that defines a first reservoir and asecond reservoir. A first septum and second septum are respectivelycoupled with the housing to provide selective access to the first andsecond reservoirs.

Each septum includes a plurality of protrusions defined about aperiphery thereof that are palpable after implantation of the port in apatient to determine a relative position of the first septum withrespect to the second septum.

A radiographically observable indicator is also included on a base ofthe housing, so as to provide information relating to a characteristicof the dual-lumen port, such as suitability for power injection offluids. The indicator in one embodiment includes a substantially rigidradiopaque component. In another embodiment, the indicator is defined asa recess in a port including a radiopaque material, such as titanium,for example.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify embodiments of the disclosure, a more particulardescription will be rendered by reference to specific embodimentsthereof that are illustrated in the appended drawings. It is appreciatedthat these drawings depict only typical embodiments of the invention andare therefore not to be considered limiting of its scope. The inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a perspective view of an example embodiment of an implantableport including a first septum and a second septum;

FIG. 2 is a schematic illustration of an embodiment of an implantableport including palpation features arranged in one example septumidentification pattern;

FIG. 3 is a schematic illustration of an embodiment of an implantableport including palpation features arranged in another septumidentification pattern;

FIG. 4 is a perspective view of another embodiment of an implantableport that includes a first septum and a second septum, and furtherincludes a ridge between the first and second septa;

FIG. 5 is a top view of an implantable port that includes a first septumand a second septum, a ridge between the first and second septa, and ahousing contour configured according to one embodiment;

FIG. 6 is a schematic illustration of an implantable port includingpalpation features arranged according to one embodiment;

FIG. 7 is a schematic illustration of an implantable port includingpalpation features arranged according to one embodiment;

FIG. 8 is a schematic illustration of an implantable port includingpalpation features arranged according to one embodiment;

FIG. 9 is a schematic illustration of an implantable port includingpalpation features arranged according to one embodiment;

FIG. 10 is a top view of an implantable port that includes a firstseptum and a second septum, a housing contour, and a plurality ofprotrusions disposed in proximate relation to the first and secondsepta, according to one embodiment;

FIG. 11 is a bottom view of the implantable port of FIG. 1, depictingfeatures of a radiopaque indicator according to one example embodiment;

FIG. 12A is an exploded view of the implantable port of FIG. 1;

FIG. 12B is an assembled bottom perspective view of the implantable portof FIG. 1;

FIG. 13 is a bottom perspective view of an implantable port including aradiopaque indicator according to one embodiment;

FIG. 14 is a schematic illustration an image of the implantable port ofFIG. 13 that can be obtained by imaging techniques;

FIG. 15 is a schematic illustration, such as that of FIG. 14, of anotherembodiment of an implantable port;

FIG. 16 is a bottom view of another embodiment of an implantable port;

FIG. 17 is a bottom view of another embodiment of an implantable port;

FIG. 18 is a bottom view of another embodiment of an implantable port;

FIG. 19 is a top view of a radiographic indicator configured inaccordance with one embodiment;

FIG. 20 is a top view of a radiographic indicator configured inaccordance with one embodiment;

FIG. 21 is a top view of a radiographic indicator configured inaccordance with one embodiment;

FIG. 22 is a top view of a radiographic indicator configured inaccordance with yet another embodiment;

FIG. 23 is a bottom perspective view of an implantable port including anindicator according to one embodiment; and

FIGS. 24A and 24B are cross sectional views of an edge of an indicator,such as the indicator shown in FIG. 12A.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the invention, and are not limiting of the presentinvention nor are they necessarily drawn to scale.

FIGS. 1-22 depict various features of embodiments of the presentinvention, which are generally directed to ports, also referred toherein as access ports, for implantation into the body of a patient. Insome situations, it can be desirable to facilitate access to thevasculature of a patient for purposes of blood withdrawal and/orinfusions, such as when the patient is ill and may repeatedly undergosuch procedures. In some instances, a catheter is situated within ablood vessel of the patient and a port is placed in fluid communicationwith the catheter. Accordingly, infusions and blood withdrawals may bemade via the port, rather than directly through the wall of a bloodvessel. In some situations, it can be advantageous to implant the portwithin the patient.

Reference is first made to FIG. 1, wherein an implantable port 10 isdisclosed as configured in accordance with one example embodiment. Asshown, the port 10 includes a housing 20 that defines a first reservoir31 and a second reservoir 32. A stem 35, which extends from the housing20, is configured for coupling with a dual lumen catheter 36. The stem35 defines a first fluid passageway 41 configured to couple with a firstlumen 37 of the catheter and a second fluid passageway 42 configured tocouple with a second lumen 38 of the catheter. The first and secondfluid passageways 41, 42 are in fluid communication with the first andsecond reservoir 31, 32, respectively.

In the present embodiments, the port 10 includes a first septum 51 and asecond septum 52. The first septum 51 is coupled with the housing 20 andis configured to provide selective communication with the firstreservoir 31. For example, the first septum 51 includes an elastomericmaterial capable of being punctured by a needle, for example, a Huberneedle, and substantially resealing upon removal of the needle.Similarly, the second septum 52 provides selective communication withthe second reservoir 32.

According to the present embodiment, the first septum 51 defines aplurality of palpation features, such as protrusions 71A, 71B, 71C.Similarly, the second septum 52 defines a plurality of protrusions 72A,72B, 72C. In the illustrated embodiment, the protrusions 71A, 71B, 71Cdefine end points, or vertices, of a triangle, for example, anequilateral triangle, and are spaced at approximately regular intervalsaround the periphery of the first septum 51. Similarly, the protrusions72A, 72B, 72C define end points, or vertices, of a triangle, forexample, an equilateral triangle, and are spaced at approximatelyregular intervals around the periphery of the second septum 52. Theprotrusions 71A, 71B, 71C and 72A, 72B, 72C extend outward from theseptum surface such that the protrusions define a portion of top profileof the port 10 from the perspective of the port as shown in FIG. 1.

The port 10 is configured to be implanted subcutaneously within apatient. Accordingly, when the catheter 36 is coupled with the stem 35and inserted in a blood vessel of the patient, fluid communication canbe established with the blood vessel via one of the first and secondreservoirs 31, 32, such as by an infusion needle inserted through acorresponding one of the septa 51, 52.

As seen in FIG. 1, each protrusion 71A, 71B, 71C and 72A, 72B, 72C isshaped to define a substantially hemispherical shape to provide a smoothsurface and to avoid irritating body tissue proximate the port implantedlocation. In other embodiments, though, the shape, size, number, andplacement of the palpation features can be modified from what isexplicitly shown and described herein in order to suit a particularneed. For instance, the protrusions can define a geometric or oval shapein one example. In one embodiment, the protrusions extend a distance ofabout 0.1 inch above the surface of the corresponding septum 51, 52,though other size dimensions are of course possible. The protrusions71A, 71B, 71C and 72A, 72B, 72C are integrally formed with thecorresponding septum 51 or 52, in one embodiment.

The palpation features, i.e., protrusions 71A, 71B, 71C and 72A, 72B,72C, of the first and second septa 51, 52 can permit a clinician toproperly identify the number of septa 51, 52 included in the port 10, aswell as the location and orientation of the desired septa, bothgenerally and with respect to one another, in preparation for a givenprocedure (e.g., insertion of an infusion needle into a particularseptum). For example, in many embodiments, when the port 10 is implantedsubcutaneously in a patient, the clinician cannot visually distinguishthe location of the first septum 51 from that of the second septum 52,especially for ports made from radio-translucent materials, which arenot sufficiently imaged radiographically. The clinician can instead feelor palpate the protrusions 71A, 71B, 71C and 72A, 72B, 72C through theskin to determine the general orientation of the port 10, the locationthe septa 51, 52, and/or to distinguish the location of one septum fromthat of the other. In one embodiment, the palpation protrusions furtherindicate suitability of the port for high fluid flow rate and/or highfluid pressure flow therethrough, such as power injection. These andother characteristics of the port can be indicated by the e protrusionsdescribed herein.

In many instances, a clinician has a need to properly identify thedesired septum 51, 52. For example, in some instances, it can beundesirable for the clinician to mistakenly puncture the same septumtwice when the clinician's intent is to use each septum separately. Itcan also be undesirable for the clinician to mistakenly fail to punctureeither septum and miss the port entirely. Accordingly, the protrusions71A, 71B, 71C and 72A, 72B, 72C are arranged in present embodiments inan identification pattern to reduce the likelihood of clinicianconfusion and/or error when identifying the location and/or orientationof the septa 51, 52.

FIG. 2 is a schematic illustration of an embodiment of the port 10having protrusions 71A, 71B, 71C and 72A, 72B, 72C arranged in a firstseptum identification pattern 100. In the illustrated embodiment, theidentification pattern 100 includes a plurality of sub-patterns 105A,105B, 105C. Each sub-pattern 105A, 105B, 105C substantially defines atriangular shape. Each set of protrusions 71A, 71B, 71C and 72A, 72B,72C separately defines one of the sub-patterns 105A, 105B, respectively,and the protrusions 71A of the first septum 51 and the protrusions 72B,72C of the second septum 52 cooperate to define a third sub-pattern105C.

FIG. 3 is a schematic illustration of an embodiment of the port 10having protrusions 71A, 71B, 71C and 72A, 72B, 72C arranged in a secondseptum identification pattern 110. In detail, the protrusions 71A, 71B,71C define an equilateral triangle sub-pattern 115A bisected by a longaxis 90 of the port 10 (see also FIG. 1). Similarly, the protrusions72A, 72B, 72C define an equilateral triangle sub-pattern 115B oppositelypositioned with respect to the triangle defined by the protrusions 71A,71B, 71C and which is also bisected by the port long axis 90.

A perimeter or outline of the pattern 110 defines a pattern that canreadily assist a clinician to determine a characteristic of the septa51, 52 with respect to the one another. In particular, the pattern canassist a clinician in distinguishing the relative locations of the septa51, 52. For example, the opposing edges, defined by the protrusions 71A,71B and 72B, 72C, respectively, of the pattern 110 can help a clinicianto determine that more of the surface areas of the septa are between theopposing edges of the pattern than outside of the opposing edges. Inaddition, the pattern 110 does not include any sub-patterns that areconfusingly similar to the triangular sub-patterns 115A, 115B. Inanother implementation, the pattern 110 can assist a clinician indetermining a general orientation of the port 10 as implanted within thepatient.

FIG. 4 depicts another embodiment wherein palpation features areincluded on an implantable port. In particular, a port 210 includes ahousing 20 that defines a ridge 220 between the septa 51, 52. As before,the first septum 51 defines a plurality of palpation features includingprotrusions 71A, 71B, 71C, while the second septum 52 defines aplurality of palpation features including protrusions 72A, 72B, 72C. Theprotrusions 71A, 71B, 71C and 72A, 72B, 72C are arranged as opposingequilateral triangles in mirror-image to one another, similar to thepattern 110 shown in FIG. 3. The ridge 220 can further aid indistinguishing the locations of the septa 51, 52.

FIG. 5 depicts another embodiment wherein palpation features areincluded on an implantable port. In particular, a port 310 includes ahousing 20 that defines a ridge 325 between the septa 51, 52. As before,the first septum 51 defines a plurality of palpation features includingprotrusions 71, while the second septum 52 defines a plurality ofpalpation features including protrusions 72. The protrusions 71 and 72are arranged as opposing equilateral triangles, similar to the pattern110 shown in FIG. 3. The ridge 325 can further aid in distinguishing thelocations of the septa 51, 52. Note that the housing defines arelatively more contoured outline than in the embodiments shown in FIGS.1 and 4.

FIGS. 6-9 depict further examples of palpation feature configurationsfor the implantable port, according to example embodiments. FIG. 6 showstwo oppositely positioned protrusions 171A, 171B included on theperiphery of the septum 51, and two similarly positioned protrusions172A, 172B included on the periphery of the septum 52. The protrusions171A, 171B and 172A, 172B are positioned at about 0 and 180 degree“compass” positions on their respective septa 51, 52, though it isappreciated that the respective positions of the protrusions can bemodified from what is shown here.

FIG. 7 shows four equally spaced protrusions 271A, 271B, 271C, 271Dincluded on the periphery of the septum 51, and four equally spacedprotrusions 272A, 272B, 272C, 272D included on the periphery of theseptum 52. The protrusions 271A, 271B, 271C, 271D and 272A, 272B, 272C,272D are positioned at about 0, 90, 180, and 270 degree compasspositions on their respective septa 51, 52, though it is appreciatedthat the respective positions of the protrusions can be modified fromwhat is shown here.

FIG. 8 shows four equally spaced protrusions 371A, 371B, 371C, 371Dincluded on the periphery of the septum 51, and two equally spacedprotrusions 372A, 372B included on the periphery of the septum 52. Theprotrusions 371A, 371B, 371C, 371D are positioned at about 0, 90, 180,and 270 degree compass positions on the septum 51, while the protrusions372A, 372B are positioned at about 90 and 180 degree compass positionson the septum 52, though it is appreciated that the respective positionsof the protrusions can be modified from what is shown here.

FIG. 9 shows three equally spaced protrusions 471A, 471B, 471C includedon the periphery of the septum 51, and three equally spaced protrusions472A, 472B, 472C included on the periphery of the septum 52. Theprotrusions 471A, 471B, 471C and 472A, 472B, 472C are positioned todefine vertices of imaginary equilateral triangles on their respectivesepta 51, 52 such that the bases of each triangle face one another todefine a septum identification pattern 480.

FIG. 10 depicts yet another embodiment wherein palpation features areincluded on an implantable port. In particular, a port 510 includes ahousing 20 defining two apertures into which the septa 51, 52 areinserted, as before. A plurality of protrusions 571 are included on anddefined by the port housing 20 proximately adjacent the periphery of thesepta 51, 52. The protrusions 71 and 72 define vertices of opposingequilateral triangles, similar to the pattern 110 shown in FIG. 3. Thusit is noted that the palpation features can be included on either areasof the port in addition to the septa. Note further that the housingdefines a relatively more contoured outline than in the embodimentsshown in FIGS. 1 and 4, thus illustrating that the shape of the housing20 can vary from what is described herein.

As the embodiments above make clear, the number, size, position, andshape of the palpation features can be modified while residing withinthe scope of embodiments of the present invention. In addition to theabove embodiments, it is appreciated, for example, that the protrusionscan define sub-patterns other than equilateral triangles, includingacute triangles, obtuse triangles, etc. Additionally, one or more, twoor more, three or more, four or more, five or more, etc. protrusionscould be used, and need not be arranged about the periphery of thesepta. In various embodiments, the port comprises two or more septa withprotrusions extending therefrom. The protrusions can define a variety ofdifferent shapes, and may be sized differently. Thus, the foregoingexamples are merely illustrative in nature.

Reference is now generally made to FIGS. 11-22 in describing variousdetails regarding further embodiments of the present invention. As hasbeen described, in many implementations, it can be desirable todetermine information regarding an access port subsequent toimplantation in the body of a patient. For example, in some embodiments,it can be desirable to determine whether the port has flipped within thebody such that the septa thereof undesirably face away from the skin atthe implantation site.

Additionally, it can be desirable to determine the number of septaincluded in an implanted port, and/or the relative orientation of thesepta. For example, it is generally desirable to determine whether aport provides fluid access to multiple lumens of a catheter operablyconnected thereto, and if so, to determine the relative orientations ofsepta associated with the lumens.

In further instances, it can be desirable to determine a functionalcharacteristic of the implanted port. For example, some embodiments ofthe port are configured to withstand relatively high pressure and flowrates typically associated with power injection of fluids through theport during relatively demanding procedures (e.g., computed tomography,or “CT,” scans), in which contrast media is rapidly infused through theport and connected catheter and into a vascular system. “Powerinjection” is defined herein to include fluid infusion under relativelyhigh flow rates and/or relatively high pressures. For instance, in oneembodiment power injection includes fluid infusion by a power injectionmachine producing fluid pressures of up to about 325 psi, resulting influid pressures in the port 10 between about 50 and about 90 psi andfluid flow through the port at a rate between about two and about fivemilliliters per second.

During power injection, a needle can be inserted in a septum of the portand connected to a power injection machine, which can introduce contrastmedia through the port at a relatively high flow rate detailed above.Certain ports may not be able to withstand pressures corresponding tohigh flow rates during power injection. Accordingly, it is oftennecessary to determine whether an implanted port is compatible for powerinjection.

With reference to FIG. 11, in one embodiment, the port 10 includes anindicator 1100 that includes radiopaque material. The indicator 1100 candefine a variety of shapes, figures, symbols, or other indicia to conveyinformation regarding a characteristic of the port 10. In someembodiments, the indicator 1100 is mounted, painted, screened on, orotherwise affixed to a bottom surface 20A primarily defined by a base 25of the port housing 20, as shown in the FIG. 11. As depicted in FIG. 11,the bottom surface 20A of the port housing 20 is defined primarily bythe base 25, and partially defined by a cap 27 that is mated with thebase during port manufacture to define the complete housing. FIG. 11further shows that the indicator 1100 is centered with respect to araised portion 25A of the base 25, though in other embodiments,placement of the indicator can vary from this configuration. Indeed, inother embodiments the indicator can be provided on another surface ofthe housing. In still other embodiments, at least a portion of theindicator can be incorporated within the housing.

In the illustrated embodiment, the indicator 1100 is an insertable pieceproduced from a radiopaque substance, such as any one or more ofsuitable metals/metal alloys. In one embodiment, the indicator 1100 isformed from a metallic material including titanium, such as titanium 64,though many other metals and other radiopaque materials could also beemployed, including stainless steel, ceramic, ceramic slurry includingceramic powder intermixed with an epoxy or resin, paintable orinjectable substances (including tungsten-filled solution), andsilk-screened products, for instance. In one embodiment, the substancefrom which the indicator piece is formed is biocompatible so as toprevent associated complications after implantation into the patient, isself-oxidizing, and is non-ferromagnetic so as to prevent imagingproblems when MRI procedures are employed. In one implementation, forinstance, the indicator piece 1100 including titanium is betweenapproximately 0.010 and about 0.020 inch thick, about 0.8 inch long, andabout 0.4 inch wide. Of course, other dimensions are possible. In oneembodiment, the insertable piece that defines the indicator 1100 isrigid before attachment to the port housing 20. In another embodiment,the indicator can be initially pliable, then solidify to rigidity eitherbefore or after attachment to the port housing.

In the illustrated embodiment, the indicator 1100 includes a firstportion 1111 and a second portion 1112. The indicator first and secondportions 1111, 1112 indicate in the present embodiment that the port 10is a dual lumen port configured for use with a dual lumen catheter.Because the indicator 1100 is radiopaque, the two portions 1111, 1112will be visible through imaging techniques, such as radiographic (x-ray)imaging. Thus, a clinician viewing a radiographic image taken of theregion of the patient in which the port 10 is implanted can see thex-ray shadow of the indicator 1100 on the image and understand that theport, by its inclusion of the two portions 1111 and 1112, includes twosepta 51, 52.

In greater detail, the indicator portions 1111 and 1112 defineequilateral triangles positioned side-by-side. Indicia 1114 are includedon the indicator first and second portions 1111, 1112 to conveyadditional information regarding the port 10. In the illustratedembodiment, the indicia 1114 include alphanumeric characters, such as“C” and “T,” defined within the triangular portions, which indicate thatthe port 10 is suitable for use with power injection. The indicia 1114included in the indicator are reversed, or backwards, when reviewed frombelow as in FIG. 11 such that the indicia will appear non-reversed whenradiographically imaged from a vantage point above the port 10. Both thefirst and second portions 1111, 1112 of the indicator 1100 include aplurality of holes 1116 defined therein so as to reduce heat sinkingwhen the indicator is heat bonded to the port base 25, as explainedfurther below.

The exploded view of the port 10 in FIG. 12A shows that the indicator1100 is sized to fit within a cavity 1120 defined on the port bottomsurface 20A, more specifically the raised portion 25A of the port base25. In one embodiment, the port base and cap 25, 27 are composed of anengineering plastic polymer material including Polyoxymethylene (“POM”),also known as an acetyl resin, and the cavity 1120 is defined as part ofthe molding process that defines the port base 25. In anotherembodiment, the cavity 1120 is defined by machining or other suitableprocess after the port base 25 has been produced. The indicator 1100 inone embodiment is attached to the port base in the cavity 1120 by heatbonding during the same ultrasonic welding process that joins the portbase 25 to the port cap 27. The holes 1116 (FIG. 11) are included in theindicator 1114 to prevent excessive heat sinking during the ultrasonicwelding process, thus ensuring an adequate attachment of the indicatorto the port base 25.

In another embodiment, the indicator can be press-fit into the cavity1120. In yet another embodiment, a combination of press-fitting andultrasonic welding can be employed to attach the indicator 1100. Ofcourse, other suitable attachment methods can also be pursued, includinginsert molding the indicator into the port base, and other materials maybe used to form the port base and cap. FIG. 12B shows the port 10 andindicator 1100 after attachment of the indicator on the bottom surface20A is complete.

The indicator described herein can indicate various characteristics ofthe multi-lumen port, including suitability of the port for powerinjectability (described above), the number or reservoirs included inthe port, and the orientation and position of the septa of the port.

FIG. 13 shows the indicator 1100 of the port 10 according to anotherembodiment, wherein each of the indicator first and second portions1111, 1112 includes a substantially circular outline 1165, 1166. Thefirst and second portions 1111, 1112 further include rounded inwardextensions 1171A, 1171B, 1171C, 1172A, 1172B, 1172C, which are intendedto convey that protrusions, such as the protrusions 71A, 71B, 71C and72A, 72B, 72C are provided on the septa 51, 52, as seen in FIG. 1. Inone embodiment, the circular outlines 1165, 1166 and the inwardextensions 1171A, 1171B, 1171C, 1172A, 1172B, 1172C correspond to anormal projection of the outer perimeter of the septa 51, 52 onto theport bottom surface 20A. The first and second portions 1111, 1112further include indicia, such as the flipped or reversed letters “C” and“T,” as shown.

FIG. 14 illustrates an image 2160 of the port 10 that can be obtained byimaging techniques, such as radiographic imaging, ultrasound imaging, orother suitable techniques. As shown, the image 2160 includes informationconveyed by the various indicator components described above, which canbe readily perceived by a clinician observing the image. For example,the indicia letters “C” and “T” indicate to the clinician that the port10 is power-injection compatible. Further, the non-reversed orientationof the imaged letters indicates that the port 10 is properly positioned,i.e., not flipped within the patient. The images of circular outlines1165, 1166 and of the inward extensions 1171A, 1171B, 1171C, 1172A,1172B, 1172C can indicate that the port 10 includes two septa 51, 52,and further helps in determining the orientation of the septa.

FIG. 15 illustrates an image 2260 that can be obtained from anotherembodiment of the port 10, wherein an indicator 2200 is shown, includingfirst portion 2211, second portion 2212, and indicia 2214A indicatingthe entity producing the port, and 2214B indicating by the letters “CT”that the port is power injectable.

FIG. 16 depicts another embodiment of an indicator 2300, including afirst portion 2311 and a second portion 2312. In contrast to previousembodiments, the first and second portions 2311, 2312 are separate fromone another.

FIG. 17 depicts another embodiment of an indicator 2400, including afirst portion 2411 and a second portion 2412. The indicator 2400 issized in the present embodiment such that the first and second portions2411, 2412 define a plurality of end points 2418, such as triangularvertices, which extend past the bottom periphery of the base 25 and arereceived into corresponding recesses 2420 defined in the portion of thebottom surface 20A defined by the cap 27. Such a configuration enablesthe indicator 2400, as a rigid piece, to be placed by itself within themold used to form the port base 25 before molding occurs, thus allowingthe port base to be molded about the indicator. Note that, though it isshown as exposed on the port bottom surface in the present embodiments,the indicator can be integrated into the port such that it is not seenupon visual inspection.

FIG. 18 depicts another embodiment of an indicator 2500 on the portbottom surface 20A. As shown, the indicator includes a lightning bolt,which can indicate, among other things, that the port 10 includes twosepta, each of which is compatible for power injection. As the port 10is often included in a kit, the kit can include instructions for userelative to the port as well as a guide for interpreting theindicator(s) of the port.

FIG. 19 depicts an example of an indicator 2600 for use with a portaccording to one embodiment, including a triangular first portion 2611and an overlapping triangular second portion 2612. Alphanumeric indicia2614A are included with each portion 2611, 2612 to indicate powerinjection compatibility, as are inward extension indicia 2614Bcorresponding to protrusions included on the septa of the port.

FIG. 20 depicts another example of an indicator 2700 for use with a portaccording to one embodiment, including a triangular first portion 2711and an overlapping triangular second portion 2712. Alphanumeric indicia2714A are included with each portion 2711, 2712 to indicate powerinjection compatibility, as are inward extension indicia 2714Bcorresponding to protrusions included on the septa of the port.

FIG. 21 depicts another example of an indicator 2800 for use with a portaccording to one embodiment, including a triangular first portion 2811and an overlapping triangular second portion 2812. Alphanumeric indicia2814A are included with each portion 2811, 2812 to indicate powerinjection compatibility, as are inward extension indicia 2814Bcorresponding to protrusions included on the septa of the port.

FIG. 22 depicts another example of an indicator 2900 for use with a portaccording to one embodiment, including a triangular first portion 2911and an overlapping triangular second portion 2912. Alphanumeric indicia2914A are included with the indicator 2900 to indicate power injectioncompatibility. Inward extension indicia 2914B are included with thefirst and second portions 2911, 2912 corresponding to protrusionsincluded on the septa of the port. A plurality of end point extensions2918 extend from the end points of the indicator portions 2911, 2912, toenable the indicator 2900, as a rigid piece, to be placed by itselfwithin the mold used to form the port base before molding occurs, thusallowing the port base to be molded about the indicator.

FIG. 23 depicts yet another embodiment of an indicator for the port 10,wherein an indicator is formed as recess 2920 on the bottom surface 20Aof the port housing 20. The recess 2920 in FIG. 23 includes a groovedefining a double triangle shape, and a recessed “C” and “T” serving asalphanumeric indicia, though in other embodiments one of a variety ofother configurations can be defined in the port. The port housing 20 inthis embodiment includes a radiopaque material, such as titanium. Othermetallic substances, alloys, or materials can also be employed. Therecess 2920 is defined on the port housing bottom surface 20A by anysuitable process, including etching, machining, molding, etc. The depthof the recess 2920 depends on the overall size and thickness of thehousing 20. In one embodiment, the recess 2920 can be filled with afiller material, such as silicone, to provide a smooth port bottomsurface 20A. Note that the recess can be defined in reverse relief towhat is shown in FIG. 23, in one embodiment. Note also that in oneembodiment, the recess 2920 can be filled with a material that is moreor less radiopaque than the material that forms the port housing 20 toprovide a contrasting radiographic image. In one embodiment, the fillermaterial can include a ceramic slurry, as already mentioned.

Because of its formation from a sufficiently thick radiopaque material,the port housing 20 itself is generally radiopaque except for relativelythinned areas of the housing. Definition of the recess 2920 thereforeprovides a relative difference in the thickness of the port 10 whenviewed from above in a radiographic image. In other words, the portionsof the recess 2920 provide a relatively thinner obstacle for x-rays topass through than relatively thicker areas of the port, resulting inless radiopacity for the recess. Thus, the image formed by the recess2920 will appear relatively lighter on a radiographic image of the port10, enabling a clinician to perceive the shape, symbols, indicia, orother elements of the indicator defined by the recess and readilydetermine an aspect of the port, its reservoirs, and/or its septa. It istherefore appreciated that an indicator as described and contemplatedherein, can serve to provide either a greater or lesser radiopacityrelative to other portions of the implantable port.

FIGS. 24A and 24B show examples of cross sectional views of an edge ofan indicator, such as the indicator 1100 shown in FIG. 12A, for example.According to example embodiments, the indicator 1100 can be die stampedor chemically etched, e.g., one or two-sided etching, from a metalsheet. In either case, depressions or protrusions, such as theprotrusions 1100A shown in FIGS. 24A and 24B, can be formed as a result.When the indicator 1100 is later attached to the bottom surface of aport via ultrasonic bonding or heat staking, the protrusions 1100A caninteract with the reflowed material immediately adjacent thereto, thusanchoring the indicator to the port housing when the reflowed materialhas solidified.

Embodiments of the present invention may be embodied in other specificforms without departing from its spirit or essential characteristics.The described embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the present disclosure is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A method for identifying a position andorientation of a subcutaneously implanted multi-lumen access port,comprising: palpating the subcutaneously implanted multi-lumen accessport to locate a first sub-pattern of protrusions on a first septumcovering a first reservoir; palpating the subcutaneously implantedmulti-lumen access port to locate a second sub-pattern of protrusionsdifferent from the first sub-pattern of protrusions covering a secondreservoir; and imaging the subcutaneously implanted multi-lumen accessport to identify a radiographic indicator included with thesubcutaneously implanted multi-lumen access port, the radiographicindicator comprising a first portion and a second portion, wherein thefirst portion includes information regarding the first sub-pattern,wherein the second portion includes information regarding the secondsub-pattern, and wherein the first and second portions together indicatethat the subcutaneously implanted multi-lumen access port is suitablefor power injection.
 2. The method according to claim 1, wherein thefirst and second portions indicate an orientation of the subcutaneouslyimplanted multi-lumen access port.
 3. The method according to claim 1,wherein the first portion is integrally formed with the second portion.4. The method according to claim 1, wherein the radiographic indicatorincludes a recess defined in the housing, the recess beingradiographically visible relative to other portions of the housing. 5.The method according to claim 4, wherein the housing includes titanium.6. The method according to claim 1, wherein the first portion and thesecond portion are triangularly shaped.
 7. The method according to claim1, wherein the radiographic indicator includes alphanumeric indicia. 8.The method according to claim 7, wherein the alphanumeric indiciaincludes a letter “C” and a letter “T.”
 9. The method according to claim7, wherein the alphanumeric indicia is in a reverse configuration suchthat the alphanumeric indicia are in a non-reverse configuration whenviewed on a radiographic image.
 10. The method according to claim 1,wherein the radiographic indicator is received in a cavity defined on abottom surface of the housing.
 11. The method according to claim 10,wherein the radiographic indicator is attached to the housing within thecavity by ultrasonic bonding.
 12. The method according to claim 1,wherein the radiographic indicator provides information relating to anumber of septa included in the subcutaneously implanted multi-lumenaccess port.
 13. The method according to claim 1, wherein theradiographic indicator includes a radiopacity relatively greater thanthat of the housing.
 14. The method according to claim 1, wherein theradiographic indicator includes a radiopacity relatively less than thatof the housing.